This trial will investigate the efficacy and safety of intensified antiretroviral treatment that includes raltegravir and maraviroc during the early stages of HIV infection. With the proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to investigate the ability of the combination of raltegravir and maraviroc plus a standard HAART backbone to further decrease the viral load in acutely infected treated HIV infected individuals.

Change in proviral HIV-1 DNA in total CD4+ T-cells from baseline to week 48 in participants randomized to the intensified arm versus the control arm who received placebo in addition to standard HAART. [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determination of first phase HIV-1 viral decay: For comparison of plasma viral decay slopes, HIV-1 RNA collected during the first 8 weeks of the study will be used. [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

Change in GALT HIV-1 proviral DNA from baseline to week 48: The mean values will be compared from baseline to week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]

Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID) for 48 weeks and then offered open label Raltegravir and Maraviroc after 48 weeks

Drug: emtricitabine 200mg /tenofovir 300mg

emtricitabine 200mg /tenofovir 300mg QD

Other Name: Truvada

Drug: lopinavir 400 mg/ritonavir 100mg

lopinavir 400 mg/ritonavir 100mg BID

Other Names:

Kaletra

Aluvia

Detailed Description:

The trial is a prospective, randomized, double-blinded, placebo-controlled study with follow-up to 5 years. Thirty-two individuals presenting with newly diagnosed acute or early HIV-1 infection as described in the inclusion criteria will be enrolled, with sixteen randomized to each arm. Individuals will be randomized to one of two arms: the "Intensive" arm with standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400mg /ritonavir 100mg BID) + Raltegravir + Maraviroc or the "placebo" arm with standard HAART+ Placebo for 48 weeks. Another group of individuals diagnosed with acute or early HIV-1 who elect to forego early treatment will be followed as non-randomized, untreated controls. At week 48, all patients will be informed of study results. If results are positive in the intensive treatment group, the placebo group will be offered to roll-over to the intense treatment arm and followed as an open-label cohort out to five years. Participants may stop treatment at any time and withdraw from the study. If they choose to do so, they will be followed according to the standards employed for all HIV-1 patients at the Maple Leaf clinic. At the five year point, the decision to terminate treatment will be made based on the existing state of the HIV-1 literature at the time.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

The major single criterion for inclusion into the study will be the presence of confirmed acute/early HIV-1 infection, as defined by one of the three following criteria:

Positive HIV-1 antibody test result (Western blot), with a documented negative test result in the previous six months or

Participants who would have difficulty participating in a trial due to non-adherence or substance abuse

Participants with any of the following abnormal laboratory test results in screening:

Hemoglobin < 85 g/L

Neutrophil count < 750 cells/uL

Platelet count < 50,000 cells/L

AST or ALT > 5X the upper limit of normal

Creatinine > 250 umol/L

Participant with a malignancy

Participant with other significant underlying disease (non-HIV-1) that might impinge upon disease progression or death

Participant who is pregnant or who is trying to conceive

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154673